MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA MODPROF 560CC SIZER US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number MSZ-M560

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure of Implant (1924)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: visual analysis of the returned device identified one curved opening and flat creases.Weight measurement of the device identified device weight was within specification.A microscopic analysis was performed which identified one striated opening and wear abrasion.Based on the device analysis the final assessment was one striated opening in the anterior side assessed as surgical damage.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: rupture and use error.

Event Description

Healthcare professional reported unknown side "tear or rupture of a breast implant sizer noted after implant was successfully implanted." device has been explanted.

• Brand Name: NATRELLE INSPIRA MODPROF 560CC SIZER US
• Type of Device: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 10779147
• MDR Text Key: 214360986
• Report Number: 9617229-2020-17755
• Device Sequence Number: 1
• Product Code: MRD
• Combination Product (y/n): N
• PMA/PMN Number: K831566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MSZ-M560
• Device Lot Number: 3451944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention